Influenza Vaccination in Cancer Patients

Cancer Clinical Trial

Official title:

Randomized Controlled Trial to Compare Seroprotection Rate According to Timing of Influenza Vaccination in Adult Patients With Non-Hematologic Malignancies Receiving Scheduled Cytotoxic Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02213432
• Other study ID #: 1407-057-593
• Status: Terminated
• Phase: N/A
• First received: August 7, 2014
• Last updated: February 22, 2016
• Start date: September 2014
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the timing of influenza vaccination to induce higher antibody response in adult patients with non-hematologic malignancies receiving scheduled cytotoxic chemotherapy.

Description:

The participants will be stratified by the age (cut off; 60 years old) and last year influenza vaccination, and block-randomized to 2 groups; Day 1 vaccination group and Day 11 vaccination group.

Day 1 group will be vaccinated at Day 1, when the cycle of chemotherapy begins. Day 11 group will get the vaccine at Day 11, 10 days after chemotherapy begins.

As the rate of completion of study in the Day 11 group is anticipated lower than Day 1 group, we will assign the participants into Day 1: Day 11 with the different ratio; 4:5.

Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-28 days after vaccination) will be examined in all participants.

All the participants will be asked if they have any contraindication for influenza vaccine by a physician before vaccination. And they will be monitored for any adverse reaction of the vaccination after 2-4 days(phone calling) and after 21-28 days (visiting the hospital).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: August 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients who receive the scheduled cytotoxic chemotherapy every 3 weeks because of solid cancer.

Specific definition of each term is like following:

• The solid cancer includes various kinds of cancer except hematologic and lymphoid malignancies.

• Cytotoxic chemotherapy includes adjuvant, neoadjuvant or palliative purpose of chemotherapy with the planned duration at least over 3 cycles every 3 weeks.

• Targeted therapy drugs like as monoclonal antibody, tyrosine kinase inhibitor or oral chemotherapy drugs like as Xeloda are excluded.

2. Patients who did not receive the influenza vaccination yet in the current year.

3. Older than 19 years

4. Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2

5. Cell blood count meets following criteria:

• Neutrophile count = 1.5 x 10^9/L

• Platelet count = 100 x 10^9/L

• Hemoglobin = 8 g/dL

6. Patients who can understand and agreed with the informed consents.

Exclusion Criteria:

1. Patients who have any contraindication for influenza vaccination.

2. Patients who are supposed to receive the last chemotherapy at the enrollment

3. Patients who receive simultaneous radiation therapy with cytotoxic chemotherapy

4. Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect)

5. Patients with HIV and low CD 4+ T cell count (< 500/uL)

6. Patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine

7. Patients who have transplanted organ and receive immunosuppressants

8. Patients who are supposed to get prophylactic G-CSF after chemotherapy

9. Patients who are suspected to have active infectious disease.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer

Intervention

Biological:
• Different timing of influenza vaccination
The timing of Influenza vaccination for cancer patients receiving chemotherapy will be differently assigned to day 1 or day 11.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprotection rate	The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre =40 post vaccination (21-28 days)	21-28 days after vaccination	No
Secondary	Seroconversion factor	Seroconversion factor is defined as mean fold increases in geometric mean titers of the haemagglutination inhibition(HI) after vaccination, expressed as a multiple.	21-28 days after vaccination	No
Secondary	Seroconversion rate	Seroconversion rate is defined as the percentage of vaccine recipients with a fourfold increase or more in post-vaccination HI titre	21-28 days after vaccination	No
Secondary	Geometric mean titre of HI	Geometric mean titers of HI (haemagglutination inhibition) after vaccination	21-28 days after vaccination	No
Secondary	Vaccine-related adverse events	the proportion of patients with any or serious vaccine-related adverse events	within 28 days	Yes